PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Reported: July 10, 2019 Initiated: June 6, 2019 #Z-1894-2019

Product Description

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

Reason for Recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Details

Units Affected
63
Distribution
Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 63.
Why was this product recalled?
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Which agency issued this recall?
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1894-2019.